Medtronic Reusable Instruments X0601003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00721902064708), received between Sep 17, 2020 and Sep 17, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2020Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP), VIA MEDTRONIC REPRESENTATIVE, REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING PROBES FOR A L4/5/S PLIF. IT WAS REPORTED THAT WHILE CREATING THE PILOT HOLE WITH THE PROBE, A LOAD WAS APPLIED AND THE TIP BENT. DURING DRILLING A PILOT HOLE, THE TIP OF TWO UNITS OF THE REPORTED PROBE BENT. THEREFORE, ANOTHER PROBE WAS USED. THE BONE WAS HARD. THE PATIENT CAME IN CONTACT WITH THE PRODUCTS. THERE WERE NO PATIENT SYMPTOMS ,OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PRE-OP DIAGNOSIS WAS SPINAL CANAL STENOSIS. THE LEVELS IMPLANTED WERE L4/5/S. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME/ REVISION SURGERY/ ADDITIONAL SURGERY/ IN-PATIENT HOSPITALIZATION, OR PROLONGATION OF EXISTING HOSPITALIZATION. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. BOTH PRODUCTS WERE REPLACED BY MEDTRONIC PRODUCTS. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10545058 ↗